Drug Criteria and Outcomes-Development, outcomes of ambulatory clinic for H. pylori
By Marisel Segarra-Newnham, PharmD, BCPS
William F. Siebert Jr., DO, FACP
Veterans Affairs Medical Center
West Palm Beach, FL
Introduction
The discovery that Helicobacter pylori infection is the etiology for most ulcers has revolutionized treatment of peptic ulcer disease. Antibiotic treatment and eradication of this infection are now considered the standard of care.
Pharmacist-managed clinics have been successful for a variety of disease states, including H. pylori infection. Our Veterans Affairs Medical Center has a primary care team model to provide care to veterans. A pharmacist-managed clinic was developed with input from the gastroenterology and infectious diseases sections. The clinic aimed to provide the current standard of care for peptic ulcer disease to our veteran population and potentially decrease consultation with the GI section for H. pylori therapy, while increasing the number of patients treated.
Methods
Patients can be referred to the H. pylori clinic by a primary care team member. Usually, the physician, nurse practitioner, physician's assistant, or clinical pharmacist will refer patients who meet at least one of the eligibility criteria (see table, below).
| Inclusion and Exclusion Criteria for Referral to H. pylori Clinic | |
| Inclusion Critieria | Exclusion Criteria |
| Receiving continuous treatment with H2RA proton pump inhibitor, or sucralfate for peptic ulcer disease or dyspepsia | Peptic ulcer disease caused by NSAIDs |
| Documented peptic ulcer disease orgastritis by endoscopy (if available) or by symptoms | Documented Zollinger-Ellison syndrome |
| Patients who have failed therapy with any of the combinations of agents active against H. pylori | Pregnancy |
| Severe liver disease (transaminases > 3-5 × upper limit of normal) | |
| H2RAs = histamine-2 receptor antagonists • NSAIDs = nonsteroidal anti-inflammatory drugs | |
Patients with active peptic ulcer disease diagnosed with a positive biopsy are usually followed by the gastroenterology clinician and are not treated in the clinic or tested with serology. Once referred, patients are scheduled to the clinic on the next available clinic day.
The clinic is scheduled for one day per week and is managed by the infectious diseases clinical pharmacy specialist. All the primary care clinical pharmacists were educated on the clinic's evaluation and protocol to avoid multiple pharmacy clinic visits for patients being followed for other diseases (e.g., diabetes management).
The clinical pharmacist reviews the electronic medical record of each referred patient prior to the first clinic visit. Patients complete a gastrointestinal-specific questionnaire during this first visit. In the questionnaire, patients check off the GI symptoms they are experiencing and report their previous GI and general health history as well as medications taken for the complaints. Eligible patients undergo serum serology testing for H. pylori.
Empiric therapy of H. pylori infection is not recommended, even when there is a history of peptic ulcer disease. Most patients have a distant history of ulcer, and it is not usually known if the ulcer was caused by other factors such as excessive alcohol intake or use of nonsteroidal drugs. If patients have severe symptoms (e.g., weight loss) that may require endoscopic examination, they are referred to the GI clinic by the pharmacist and discharged from the H. pylori clinic.
If serology is negative and patients have an indication for chronic histamine-2 receptor antagonist (H2RA) therapy (e.g., reflux disease), the drug is continued. A referral is sent to GI if patients require treatment with proton pump inhibitors after eight weeks, according to medical center policy.
Patients with a positive serology result are treated with one of the regimens listed in the box at left depending on allergy history and concomitant drug therapy. A three-drug, one-week treatment regimen is preferred, as recommended by the American College of Gastroen terology and others.
A 28-day, two-run regimen used to be the preferred therapy at our medical center before these recommendations and newer studies were published. Due to high failure rates, the two-drug regimen is no longer recommended. This regimen is only used as a last resort in patients with allergies to metronidazole and amoxicillin who cannot comply with the more complex four-drug, two-week regimen.
Patients receive specific counseling about the medication regimen, treatment expectations, side effects, and the pathology of H. pylori infection. (See H. pylori patient education handout, p. 8.) These patients are instructed to discontinue chronic H2RA therapy while taking the H. pylori regimen. Patients are followed for one year post-therapy.
If symptoms return or are unchanged after antibiotic therapy (without history of reflux), patients are referred to the GI clinic. If patients have a history of reflux and symptoms return after therapy, they are instructed to restart H2RA therapy and to continue lifestyle modifications. A serology test is not repeated after therapy.
Results
In the first year of clinic operation, 127 patients were seen, with a total of 83 patients receiving treatment for H. pylori infection. All these patients received a three-drug, one-week regimen. Most patients received clarithromycin and amoxicillin with a proton pump inhibitor; only seven received clarithromycin with metro nidazole with a proton pump inhibitor because of penicillin allergy.
Twenty-six patients (31.3%) are still on chronic medications for reflux disease; however, half of them report a decrease in frequency of symptoms after H. pylori therapy. Thirteen patients (15.7%) have been treated within the last 30 days; therefore, it is too early to assess the need for continuation of chronic therapy.
Forty-four patients (53%) are no longer on chronic medications. These patients have de scribed their symptoms as less severe or absent after treatment for H. pylori infection, and all are satisfied or very satisfied with treatment. Five of these patients have been seen for their one-year follow-up and report no GI complaints without any medication.
The outcomes of patients seen in the clinic but not treated for H. pylori infection are recorded in the table above.
| Outcomes of Patients Not Treated for H. pylori Infection (N = 44) | |
| Outcome | N |
| Referred to GI without serological testing | 12 |
| Referred to GI after negative serology (severe symptoms or proton pump inhibitor therapy) | 7 |
| Negative serology, continue medications for reflux | 16 |
| Lost to follow-up | 2 |
| No indication for chronic therapy or serology testing | 7 |
Only one treatment failure has been documented to date (positive biopsy). The patient received a second course of therapy with the four-drug, two-week antibiotic regimen prescribed by a GI clinician and does not have further symptoms. Six patients had active ulcer disease at the time of diagnosis.
All those ulcers were diagnosed with an upper GI series. Of those, two patients have had a documented negative biopsy for H. pylori post-therapy. Endoscopy was performed to document healing of gastric ulcer in one patient and to document healing of grade IV ulcerative esophagitis in the second patient.
Cost savings from using a three-drug, one-week regimen instead of the two-drug, 28-day regimen is $7,885, or approximately $95 per patient. Cost savings from chronic therapy for the 44 patients no longer on therapy amounts to $1,700 and is annualized to $6,600. Seventy-two percent of the H2RA prescriptions were for generic cimetidine.
The GI practitioners report a decrease in consults for the treatment of H. pylori infection in patients that do not have an indication for endoscopic examination. Only two patients were treated by the other clinic pharmacists outside the H. pylori clinic and are not included in this report. However, the team clinical pharmacists did help other primary care team members identify and refer appropriate patients to the H. pylori clinic.
Discussion
Treating H. pylori infection has been shown to be cost-effective compared to chronic therapy with acid-suppressive medications. The one-week regimens preferred in our clinic have been shown to be the most cost-effective compared with longer treatment. These regimens are simpler and may result in better treatment adherence compared to multiple-daily-dosing, two- week regimens. Some clinicians considered these one-week regimens as the new standard of therapy.
A pharmacist-managed H. pylori clinic using a four-drug therapy for two weeks reported that 52.3% of the patients could get off chronic medications within the clinic's first six months of operation. This is similar to our 53% success rate with a regimen of shorter duration.
One year of generic cimetidine costs our medical center $60, compared to more than $200 for brand name H2RAs. The cost of therapy and serology testing is about $55 per patient; therefore, full savings cannot be realized in a short period of time when patients are receiving cimetidine therapy.
A pharmacist-managed H. pylori clinic can offer the standard of care to patients while potentially decreasing the workload of GI specialists. This clinic has raised the awareness of practitioners about this disease and its proper diagnosis and treatment.
[For more details, contact Marisel Segarra-Newnham, PharmD, BCPS, Clinical Pharmacy Specialist in Infectious Diseases, Veterans Affairs Medical Center, 7305 North Military Trail, West Palm Beach, FL 33410. (800) 827-1000.]
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